Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Ozanimod
Sphingosine 1-phosphate receptor 5 modulator
What it measured
Main measures
Maximum plasma concentration (Cmax)
24 hours after the last RPC1063 dose on Day 85
How the body handles the medicineArea under the plasma concentration-time curve (AUC)
Approximately 3 months
How the body handles the medicine
Other measures (3)
Adverse Events
Up to 28 days after the last RPC1063 dose
SafetyEDSS (Expanded Disability Status Scale)
Up to the last RPC1036 dose on Day 85
Disability progressionPharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count
Up to 28 days after the last RPC1063 dose
Immune response
Who could take part
Relapsing MS · 18 to 55 · EDSS 0 to 6.0
Show the full criteria
Inclusion criteria
Key Inclusion Criteria: * MS, as diagnosed by the revised 2010 McDonald criteria * Exhibits a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS * Expanded disability status scale (EDSS) score between 0 and 6.0 Key Exclusion Criteria: * Primary progressive MS * Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS.
Papers
Results
Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS.Neurol Neuroimmunol Neuroinflamm · 2020
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History
Started
Jun 2016
Main results due
Oct 2017
Finished
Oct 2017